Dishonest Medical Research - Will Transparency Bring Integrity?

National Institutes of Health Director Elias A. Zerhouni has bowed to congressional pressures and public criticism announcing a drastic set of new anti-corruption rules for thousands of scientists and indeed all employees of the institution. No more stocks, consulting fees or other income from pharmaceutical companies, is the simple prescription.

How deep seated the culture of unethical and fraudulent medical experimentation has become is perhaps exemplified by a recent report in the New York Times which reveals that in experimental cancer studies, performed at the Stratton Veterans Affairs Medical Center in Albany, patient records were falsified in the recruiting process endangering veterans' lives.

How to remedy the situation? Transparency is essential, believes NIH director Zerhouni who, after the internal reforms designed to decrease pharmaceutical influence on scientific activity, has now asked that researchers receiving NIH grants should publish their papers in the Pub Med central database run by the National Library of Medicine. According to a Reuters article, the move is seen as a challenge to scientific journals which normally publish such research. The article mentions Science, Nature and The New England Journal of Medicine.

Certainly making more research openly accessible would be a good start, and if the promise of pharmaceutical companies to publish their studies on websites ever does come through, we might see some much needed changes.

It seems that historically, the British Medical Journal has been considered "a tough nut to crack" by pharmaceutical firms, saying it is difficult to obtain publication of research favourable to this or that drug. In a comment to the BMJ, Stefan Kruszewski, a psychiatrist from Harrisburg, Pennsylvania, implores the journal to

"expose published studies whose conclusions are not corroborated by the research results; where statistical analysis is simply a means to achieve a positive result rather than a meaningful analysis of benefit and reward; and when sloppy and uncontrolled clinical research designs merit neither statistical analysis nor publication."

Kruszewski is a whistleblower, fired for exposing abuses of psychiatric patients in the Pennsylvania Department of Public Welfare.

Vera Hassner Sharav of the Alliance for Human Research Protection is skeptical about the new developments at the National Institutes commenting that

"greed and corrupt research practices have engulfed the NIH. And much as 'Stratton officials turned a blind eye to unethical cancer research practices and punished those who spoke out against them' so did NIH administrators."

- - -

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountabilitywww.ahrp.org

Paul H. Kornak pleaded guilty to fraud, making false statements and criminally negligent homicide in the death of an Air Force veteran, James DiGeorgio—one of the patients he used as subjects in medical experiments that he conducted at the Veterans Affairs Medical Center in Albany. Kornak admitted that he had conducted such medical experiments without an MD license, had falsified patients’ records, and exposed patients to hazardous experimental treaments. Kornak was convicted of homicide and is awaiting sentencing in May.

Kornak’s lawless research conduct was facilitated by a failed system: "Research violations were a way of life at Stratton for 10 years," said Jeffrey Fudin, a pharmacist at the hospital. "Stratton officials turned a blind eye to unethical cancer research practices and punished those who spoke out against them.”

The New York Times reports that according to the F.D.A., “patients' medical records were altered in at least five experimental drug studies, enabling veterans like Mr. Steubing to be enrolled in studies for which they were either too sick or too healthy to qualify. A patient with coronary disease, for instance, was enrolled in a study that excluded heart patients because of a risk of hemorrhages. A patient with impaired renal function was administered a drug toxic to kidneys that probably contributed to his death, the agency said.”

Veterans at the Albany VA facility are pretty much a captive population, having no alternative treatment options outside the system. The case, however, is a demonstration of systemic failure--not only at VA facilities. Patients at prestigious academic medical centers are also not protected from experiments that expose them to undisclosed risks--their welfare and best interest are often disregarded, as local institutional review boards (IRBs) rubber stamped their approval. Vulnerable patients are often enrolled in experiments not designed to protect their welfare or to serve their best interest.

For example, critically ill patients in intensive care units at some of the nation’s most prestigious hospitals were recruited into a federally funded, multi-site experiment conducted by the ARDSNet affiliated hospitals. The subjects of the experiment were withdrawn from the individualized treatment prescribed by critical care specialists, and randomly assigned to one of two extreme treatment methods for pumping oxygen into their lungs. The patients’ condition, in most cases, precluded their ability to give or withhold informed consent. They were conscripted without consent, without full disclosure of the risks or alternative treatment available—the number of patients who may have died who might have lived had they remained on the individually selected treated outside of the research protocol, is in dispute. See: http://www.ahrp.org/infomail/0902/25.php

The Times observes: “In the 1990's, because of a marathon of new drug development, the field of clinical research grew into a multibillion-dollar industry, overwhelming the systems developed to protect human research subjects. The ethical model for those systems was born in 1947 after German physicians were convicted for performing crippling and deadly medical experiments on concentration camp prisoners. But the Nuremberg Code did not stop unethical research.”

Kornak, the NY Times points out, was “a certified clinical research professional who had passed an examination covering such ethical topics as informed consent and clinical fraud.” Just about anyone can become an NIH certified “clinical research professional.” I personally took an online exam administered by NIH and passed within 6 minutes. Such pro-forma “certification” is testimony to the low standards required by NIH for “ethical research certification” demonstrates the cynicism underlying the current “research protection system.”

As recent investigative reports in the Los Angeles Times and the Associated Press have revealed, greed and corrupt research practices have engulfed the NIH. And much as "Stratton officials turned a blind eye to unethical cancer research practices and punished those who spoke out against them” so did NIH administrators.

ALBANY - Carl M. Steubing, a decorated Battle of the Bulge veteran whose experience of war made him a pacifist but also instilled in him a zest for living life at full tilt, took his diagnosis of gastroesophageal cancer in 2001 as a challenge. With a thatch of white hair and a rich baritone voice, Mr. Steubing, at 78, was not ready to succumb to illness. A retired music educator and wedding photographer, he remained active as a church choir director, expert cook, painter, golfer and fisherman. He was married to a woman 24 years his junior, and they had seven children and three grandchildren between them.

Mr. Steubing jumped at the chance to participate in an experimental drug study at the Stratton Veterans Affairs Medical Center in Albany, believing it offered him the hope of surviving longer. The research coordinator, Paul H. Kornak, told Mr. Steubing that he was "just a perfect specimen," with the body of a man half his age, according to Jayne Steubing, Mr. Steubing's widow. He was not, though. Because of a previous cancer and poor kidney function, Mr. Steubing was not even eligible to participate in the experiment, according to government documents. Mr. Kornak, however, brushed that obstacle aside. He altered Mr. Steubing's medical records, according to prosecutors, and enrolled him in the study. He also posed as a doctor. In 2001, Mr. Steubing endured about six periodic treatments with an aggressive three-drug chemotherapy combination. Each infusion made him violently ill and forced his hospitalization. He died in March 2002.

Last month, at the federal courthouse in Albany, Mrs. Steubing glared at Mr. Kornak, 53, as he pleaded guilty to fraud, making false statements and criminally negligent homicide in the death of an Air Force veteran, James DiGeorgio. When Mr. Kornak admitted to falsifying the medical data of "subject initials CMS" - Carl M. Steubing - Mrs. Steubing's face crumpled. Mr. Kornak, who is scheduled to be sentenced in May, also agreed to cooperate in a widening investigation of the hospital's cancer research program. From 1999 to 2003, when he worked there, scores of veterans were, at the least, put at risk. But allegations of carelessness, fraud and patient abuse in the hospital's cancer research program predated Mr. Kornak, and employees say that administrators not only dismissed their concerns, but harassed them for standing up for the veterans.

"Research violations were a way of life at Stratton for 10 years," said Jeffrey Fudin, a pharmacist at the hospital. "Stratton officials turned a blind eye to unethical cancer research practices and punished those who spoke out against them. The whole Kornak episode could have been prevented." According to Mr. Kornak's lawyer, E. Stewart Jones, there was a "clear systems failure," permitting a research culture where "rules weren't followed, protocols weren't applied and supervision was nonexistent."

It was also a culture whose descent into criminality forced the Department of Veterans Affairs nationwide to reckon with what an internal memorandum in 2003 described as "systemic weaknesses in the human research protections program, especially in studies funded by industry." Excluding simple chart reviews, about 80 percent of the department's human research is financed by industry. The private sector pumps considerable cash into the system. In Albany, it accounted for $500,000 of the $1.15 million in research funding in 2004.

Mr. Kornak, who declined to be interviewed, does not appear to have derived financial gain from his fraud. The Albany hospital's research program, however, stood to benefit from the enrollment of patients, pulling in $5,000 from the drug company Aventis for Mr. Steubing's participation. Although veterans knew him as "Dr. Kornak," Mr. Kornak was not licensed to practice medicine. Mrs. Steubing first learned this a year after her husband's death when she read an article in The Times Union of Albany. By 1993, Mr. Kornak had obtained and lost medical licenses in several states by forging his credentials and had pleaded guilty in Pennsylvania to felony fraud charges. The Albany hospital hired Mr. Kornak, who did attend some medical school, as a research coordinator, not as a physician. Nonetheless, he performed physical examinations, and his Veterans Affairs business card identified him as an M.D.

James A. Holland, Mr. Kornak's supervisor, was the real M.D. and the principal oncology researcher. Federal prosecutors said in court papers last year that Dr. Holland, too, was possibly facing criminal charges. Dr. Holland, who now works at Archbold Memorial Hospital in Thomasville, Ga., declined to comment. Archbold, in a statement, said Georgia's medical board had investigated Dr. Holland's actions in Albany and found no evidence of misconduct.

In September, however, the Food and Drug Administration started proceedings to disqualify Dr. Holland from conducting further clinical research because he had "failed to protect" subjects under his care in Albany. According to the F.D.A., patients' medical records were altered in at least five experimental drug studies, enabling veterans like Mr. Steubing to be enrolled in studies for which they were either too sick or too healthy to qualify. A patient with coronary disease, for instance, was enrolled in a study that excluded heart patients because of a risk of hemorrhages. A patient with impaired renal function was administered a drug toxic to kidneys that probably contributed to his death, the agency said. "It kills me to think that the V.A. system deceived us," said Mrs. Steubing, the director of an upstate school for emotionally troubled children. "You see these youngsters at Walter Reed now and everybody's raving about the care they get. Well, Carl was one of those kids once, with a Bronze Star, a Purple Heart. And at the end of his life, his treatment was the antithesis of what you see on TV. It was such a betrayal."

It can be hard to determine whether an experimental treatment is the cause of a cancer patient's death. Mrs. Steubing will never know if her husband might have survived longer if he had undergone standard chemotherapy treatment or if he might have been spared the suffering he endured after each experimental infusion. The questions will always plague her, she said. But, as Mr. Kornak's homicide conviction indicates, the authorities have attributed one death directly to his fraud. In 2001, Mr. DiGeorgio, 71, declined precipitously and died within two weeks of being infused with experimental drugs that he should not have been given. "My husband trusted and confided in the V.A. in Albany, and he wouldn't go nowhere else," Judith DiGeorgio, his widow, said. "It's a disgrace what they did to him."
Jon A. Wooditch, a deputy inspector general for Veterans Affairs, said department employees were forbidden to answer questions for this article because of the continuing investigations. Officials from the inspector general's office have been questioning hospital employees in the last several weeks.

After Mr. Kornak's guilty plea, the hospital director, Mary-Ellen Piché, circulated a letter to the staff noting "many improvements in research since the events," among them that "credentials of researchers have been checked and confirmed" and that researchers have undergone ethics training. Mr. Kornak, as it turns out, was so trained. As a certified clinical research professional, he had passed an examination covering such ethical topics as informed consent and clinical fraud. Both Mrs. Steubing and Mrs. DiGeorgio have sued Mr. Kornak, Dr. Holland and the Department of Veterans Affairs. Mrs. Steubing's complaint, in a class-action suit, says that veterans were treated like "guinea pigs."

Overwhelmed Watchdogs: In the 1990's, because of a marathon of new drug development, the field of clinical research grew into a multibillion-dollar industry, overwhelming the systems developed to protect human research subjects. The ethical model for those systems was born in 1947 after German physicians were convicted for performing crippling and deadly medical experiments on concentration camp prisoners. But the Nuremberg Code did not stop unethical research.

Well into the 1970's, the federal government sponsored human radiation experiments and the Tuskegee experiments, in which black men with syphilis were studied but not treated or told they had the disease. Outrage over the Tuskegee experiments led to the gradual development of federal regulations governing clinical research. These regulations established the cornerstone protections for human subjects: a voluntary, informed consent process and oversight by an institutional review board, which would evaluate and monitor the scientific validity and ethical standards of studies.

In the 1990's, however, the surge in drug research strained the institutional review boards and raised new questions about conflicts of interest and government oversight. Veterans Affairs doctors have done pioneering research on spinal cord injuries and schizophrenia and helped develop the cardiac pacemaker. But like universities and private research companies, the department has grappled with allegations of exploiting its human research subjects.

The veterans department's situation, though, was singular. Veterans, many unable to afford private health care, are a particularly captive and altruistic pool of subjects, "easy marks," said Alan Milstein, a lawyer for Mrs. Steubing. And the department's huge, taxpayer-financed health care system, despite reports of significant improvements in quality of care, has struggled with issues of mismanagement. These problems include persistent complaints about abuse of power, cronyism and reprisals against whistle-blowers.

Speaking Up, to No Avail: Years before Mr. Kornak arrived at the Albany hospital in 1999, Mr. Fudin, a clinical pharmacist there, started expressing his concerns about the treatment of cancer patients. Beginning in 1993, Mr. Fudin variously alleged that patients were placed in experimental studies without their consent, that patients who were ineligible for studies were nonetheless enrolled, and that patients were given "alternative therapies" that should have been classified as research. Veterans, he said, may have died as a result.

The former pharmacy manager, Anthony Mariano, shared his subordinate's concerns. "Every violation, I hand-delivered packets of information to the chief of research, threw them down on his desk and demanded he do something to stop the research," Mr. Mariano said. Instead, Mr. Fudin and Mr. Mariano found themselves under internal investigation. In 1996, Mr. Fudin was accused of patient abuse for refusing to dispense a certain cancer therapy. Mr. Fudin said he thought the therapy amounted to unsafe experimentation on patients. He was cleared of the charge, faced a second charge and again was cleared.

Claiming harassment and reprisal for whistle-blowing, Mr. Fudin filed a complaint with the Office of Special Counsel, a federal agency intended to protect federal employees. In late 1996, Veterans Affairs and Mr. Fudin reached a settlement. The department agreed to sponsor him for a doctorate in pharmacy by paying his tuition ($21,986) and giving him a flexible work schedule. "It is regretful that these investigations of your clinical practices took place," a senior Veterans Affairs official wrote to Mr. Fudin. Still, Mr. Fudin said he was frustrated that his concerns about the cancer research program had not been addressed. His allegations were investigated in the mid-1990's, but the doctor who conducted the inquiry, Thomas Ferro, said it was cursory and, ultimately, thwarted.

"There is always a hidden agenda either to exonerate or convict in these internal investigations," said Dr. Ferro, who is now at the Veterans Affairs hospital in Richmond. "In this case it was to exonerate. I was buddies with the doctor I was deputized to investigate."
Dr. Ferro said he did "a fairly superficial investigation only oriented toward uncovering egregious errors, of which none were found." He reviewed about 10 patient charts, he said. He found a consent form missing in one and "consent form discrepancies" in others. Dr. Ferro said he also found "creative science" in the use of "alternative chemotherapeutic regimens." He said he was convinced that the oncologist was genuinely trying to help patients survive longer. "But," Dr. Ferro said, "it didn't strike me as prudent to be using alternative regimens when there was no clear-cut evidence they were helpful and the possibility that they might be harmful." Dr. Ferro said he "watered down" his findings in his final report, stating that no major violations were found, but that "minor discrepancies" were. His superiors, however, did not like any mention of problems, and they whited out "minor discrepancies" and other negative phrases, Dr. Ferro said. They asked Dr. Ferro to initial the deletions, and he protested, but eventually did so, he said, "so as not to be a troublemaker." Dr. Ferro said he also recommended strict monitoring of cancer drug studies, and his ideas included having a chemotherapy expert "review the consent forms and review the documentation to make sure the patients were eligible for the studies." But the recommendations were shelved, he said. "The solution to the Kornak problem yet to come was in that document," he said.

Both Mr. Fudin and Mr. Mariano faced additional internal investigations. Mr. Fudin was dismissed in 2001, and an administrative law judge ordered him reinstated in 2002. Mr. Mariano, meanwhile, was criticizing a cost-saving drug substitution policy involving hypertension medication that he contended was harming patients who suffered from congestive heart failure. In 1999, after he published an article in a federal medical journal questioning the department's drug policies, he was, at one point, reassigned from the pharmacy to a locked psychiatric ward and given no duties. Eventually, after a complicated legal process, Mr. Mariano said, he resigned under pressure in 2001, and he now works as a pharmacist for Wal-Mart. Mr. Fudin and Mr. Mariano served as grand marshals for Albany's Memorial Day Parade in 2003, selected by local veterans honoring what they described as the men's courage in blowing the whistle. Some veterans wore T-shirts emblazoned with whistles and, on a rainy May day, blew whistles as they marched.

Convicted, Then Hired: In 1993 in Harrisburg, Pa., Judge William W. Caldwell of United States District Court sentenced Mr. Kornak to a $2,500 fine and three years of probation for forging his credentials to obtain a medical license. Apparently, Mr. Kornak's history of fraud began with the falsification of a college transcript, and lie followed lie until he lost a medical license in Iowa, was denied one in New Jersey and was arrested in Pennsylvania. "As we all know, a house built on sand will eventually fall, and a career whose foundation is built on deception likewise has fallen," Judge Caldwell said. "I think the conviction for this offense is going to make it extremely difficult, if not impossible, for Mr. Kornak to pursue a medical career." Six years after Judge Caldwell's pronouncement, Mr. Kornak answered an advertisement for a research assistant position at the Albany veterans hospital's research institute.

It was 1999. Dr. William Hrushesky, then the chief oncologist, interviewed Mr. Kornak, according to The Medical Research Law and Policy Report, a trade publication. (Dr. Hrushesky did not respond to inquiries from The New York Times.) Mr. Kornak told Dr. Hrushesky that he had lost his medical license because he could not document a year of medical school in Poland, according to the journal. Mr. Kornak "gave us a résumé with an M.D. on it and a lot of gaps," Dr. Hrushesky told the journal. "We decided to give him a chance."

Dr. Hrushesky also said he assumed that the research institute, a foundation that oversees industry grants for research, checked Mr. Kornak's credentials before hiring him. (Eventually, Mr. Kornak was hired away from the foundation by the veterans department itself.) But at that point, the Veterans Affairs system did not require much background or credential checking for health professionals other than for physicians and dentists, and the system did not double-check to make sure that its hospitals actually did the required screening of doctors, according to a General Accounting Office report issued last year.

Big Bucks, Big Pharma pulls back the curtain on the multi-billion dollar pharmaceutical industry to expose the insidious ways that illness is used, manipulated, and often created, for profit. Focusing on the industry's marketing practices, the video shows how direct-to-consumer pharmaceutical advertising glamorizes prescription drugs, and works to reinforce drug promotion to doctors. Pharmaceutical Research is seen as essentially uncontrolled and heavily skewed. Ultimately, Big Bucks, Big Pharma challenges us to ask important questions about the consequences of relying on a for-profit industry for our health and well-being.

NIH Chief Calls for Ethics SummitDr. Elias Zerhouni, who banned drug company payments to agency scientists, wants a wider discussion on conflicts in medical research.
By David Willman, Times Staff WriterBETHESDA, Md. — The director of the National Institutes of Health — describing consulting payments from drug companies as a "systemic problem" that threatened the integrity of his agency — has called for a summit of government and academic leaders to address conflicts of interest throughout American medical research.

LA Times - March 3, 2005New Rules Will Cost Dissidents at NIHA panel of scientists is fighting the agency's ban on consulting with drug firms. A third of them have profited from such deals in recent years.

You probably have already seen our newest, fun initiative -- the song by the Austin Lounge Lizards called "The Drugs I Need" -- so we just wanted to tell you what a success its been! In just the last two weeks, people watched the video more than 450,000 times and helped us circulate the funny message for serious reform. It's still spreading across the internet and has been featured in the New York Times (twice!), on the Today Show and Fox News, and on dozens of blogs.

Nevirapine Study Investigation - March 16, 2005 AIDS Panel Gets Money From Agency in Probe
By JOHN SOLOMON - ASSOCIATED PRESS
WASHINGTON (AP) - Six of the nine scientists serving on an expert medical panel investigating a U.S.-funded AIDS study are receiving grant money from the agency at the center of the probe, according to documents and interviews. The Institute of Medicine said it was aware of the financial ties but approved the members' participation because they have special expertise, receive only a minority of their overall dollars from the National Institutes of Health and won their grants competitively. The six panel members are receiving from $120,000 to nearly $2 million a year from the NIH, according to agency records and interviews by The Associated Press.

New law aims to distance the FDA from the drug industry
Jeanne Lenzer BMJ14 May 2005 - New York - Legislation aimed at ending the close relationship between the US Food and Drug Administration and the drug industry was introduced last week in the House of Representatives by Congressman Maurice Hinchey (Democrat) of New York.

posted by Sepp Hasslberger on Sunday February 6 2005
updated on Thursday December 16 2010

URL of this article:
http://www.communicationagents.com/sepp/2005/02/06/dishonest_medical_research_will_transparency_bring_integrity.htm

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